Cladribine Impurity N77 CAS 152463-97-3

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.152463-97-3
Molecular FormulaC18H18ClN5O4
Molecular Weight403.82 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Cladribine Impurity N77 CAS 152463-97-3 chemical structure

Description

The occurrence of Cladribine Impurity N77 is closely related to a flavonoid core, an amide group, a hydroxyl group, an ether linkage, chlorine substitution in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

CATO supplies Cladribine Impurity N77 (CAS 152463-97-3), a pharmacopoeial impurity reference standard (molecular formula C18H18ClN5O4, MW 403.82 g/mol) used for the identification and quantification of trace impurities in APIs.

The molecular framework of Cladribine Impurity N77 (C18H18ClN5O4) is characterized by a flavonoid core, an amide group, a hydroxyl group, an ether linkage, chlorine substitution. In reversed-phase chromatography, its retention is governed primarily by the protonation state of its nitrogen-containing groups, which provides a practical basis for HPLC-UV/DAD or LC-MS method development. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).

This reference standard supports related-substances testing and method development in line with ICH Q3A/Q3B guidance on impurity control, and is suitable for system suitability testing and forced-degradation studies.

CATO manufactures Cladribine Impurity N77 under ISO 17034:2016 accreditation with dual CNAS and ANAB accreditation. Each batch is characterized by orthogonal methods and supplied with a full Certificate of Analysis (COA), ensuring metrological traceability.

Physical & Chemical Properties

Molecular FormulaC18H18ClN5O4
Molecular Weight403.82 g/mol
AppearancePale yellow to yellow crystalline powder. (slight halide-like odor)
Purity97%+
StorageStore in a cool place (≤25°C), protect from light, keep sealed and dry
Solubility (reference)Soluble in DMSO, DMF, methanol
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening; Contains ester bond; hydrolyzes under strong alkaline conditions
Degree of Unsaturation (DBE)12.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)2000
Halogen ContentCl-containing
Nitrogen Atoms5

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